Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers

Summary

This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco
electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various
types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from
conventional cigarettes (the participant's own brand) may help provide information about the
use of nicotine-containing products that may help inform/reform current tobacco policy,
practice, and harm reduction approaches.

Description

PRIMARY OBJECTIVES:

I. Determine the levels of nicotine effectively delivered by various types and brands of
ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes.
(Study 1)

II. Explore the effect of flavorings added to nicotine solution on puffing topography and
nicotine delivery and, assess and compare short-term "functional" nicotine effects of the
different products by using subjective measures such as relief of craving and withdrawal
symptoms. (Study 2)

SECONDARY OBJECTIVES:

I. Determine the amounts of nicotine present in various brands and types of ENDS. (Study 3)

II. Determine nicotine yields in vapors from various types of ENDS under laboratory
conditions. (Study 4)

II. Develop and validate the analytical method for analysis of nicotine content in the
vapor.

III. Propose a standardized puffing regimen for generating vapors for analytical purposes:
Such a testing protocol will reflect the puffing behavior observed among ENDS users and
should be specific to ENDS type.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (Study 1): Participants are asked to smoke ad lib a single cigarette of their own
brand and provided with a different type of ENDS product at each visit (e-cigarette,
disposable e-cigarette, eGo, personal vaporizer, e-cigar, and e-pipe) over 3.5-4 hours at
least 7 days apart for 7 weeks. Participants are provided with cartridges of the same
amounts of nicotine with regular (tobacco) or menthol flavor according to smoker's
preference, instructed on how to use the product, asked to practice using it for 7 days, and
return to the study center for their next visit.

ARM II (Study 2): Participants are asked to smoke ad lib a single cigarette of their own
brand and provided with the BLU e-cigarette ENDS product with nicotine solution of one of
five flavors over 3.5-4 hours at least 7 days apart for 6 weeks. Participants are provided
with cartridges of maximum available amounts of nicotine and different flavors at each
visit, instructed on how to use the product, asked to practice using it for 7 days, and
return to the study center for their next visit.

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Medical and Biotech [MESH] Definitions

Electronic Cigarettes

Electronic devices that are designed to provide NICOTINE in the form of an inhaled aerosol. They typically are made in the shape of CIGARETTES in order to simulate the experience of CIGARETTE SMOKING.

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